223.664.01
Design and Conduct of Community Trials

Prerequisite:

Biostatistics 620 series or higher, and Epidemiology Methods or Professional Epidemiology courses recommended but not required

Description:

Field trials in low-income countries are needed to assess potentially useful new interventions and to develop more effective disease control strategies.

Helps students (1) critically review the community trials literature, and (2) develop, identify and justify a randomized community trial design appropriate to answer a set of specific research aims. Discusses different types of randomized study designs appropriate for community (as opposed to clinical) trials. Topics include critical review of the community trials literature, formulation of specific aims, selection of study designs and appropriate study populations, estimation of sample size, methods for allocation of interventions or treatments, grantsmanship and budgeting, community participation, consent procedures, ethical and cultural considerations, specification of key outcomes, Safety and Monitoring Boards, data management, analyses and publication of results. These methods apply in many settings, but emphasizes issues that are unique to developing country and resource constrained environments.

Learning Objectives:

Upon successfully completing this course, students will be able to:

1. Formulate a research question and design a trial
2. Describe the methods used to conduct a trial, and the types of data analysis required to answer the research question

Methods of Assessment:

This course is evaluated as follows:

• 45% Group Project(s)
• 10% In-class Exercises
• 5% Participation
• 15% Written Assignment(s)
• 25% Paper(s)

Instructor Consent:

No consent required